Office of Responsible Research Practices
The Ohio State University

Common Rule Revisions

The resources below were developed to help the Ohio State human subjects research community understand the revisions to the Common Rule that went into effect on January 21, 2019. Please check back often as updates will be made on an ongoing basis.

What the Final Rule Changes Mean for Your Research
Overview Definitions
Continuing Review Exempt Research
Informed Consent Cooperative Research

Overview of Common Rule Revisions

The Common Rule has been updated for the first time since it was issued in 1991. The Final Rule to update the current regulations at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (the Common Rule) was published by the U.S. Department of Health and Human Services (HHS) on January 19, 2017 in the Federal Register. The most significant changes that affect research institutions, Institutional Review Boards (IRBs), and investigators are provided below. Some Final Rule changes were made in an effort to clarify how the pre-2018 Common Rule is applied.The most significant revisions are intended to “modernize, strengthen, and make more effective” the current system of oversight. The revisions propose to:

  • Better protect human subjects
  • Expedite research
  • Increase trust in the research enterprise
  • Reduce regulatory burden

The Common Rule revisions aim to better manage the many types of research (specifically including behavioral and social science research) that are being conducted today, as opposed to the research conducted in 1991. One of the Final Rule’s main purposes is to facilitate the conduct of minimal risk research. It also recognizes the evolving technologies used today which have changed the scale and nature of information collected in modern research activities. Large databases, bio-specimen repositories, electronic health records, and clinical research networks have shifted research priorities.